Amanda Parrish, PhD, RAC
Director of Regulatory Affairs and Quality
Phone: (919) 668-8772
Amanda Parrish, PhD, RAC is the Director of Regulatory Affairs and Quality in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Parrish oversees a team of Regulatory and Quality professionals who provide guidance on FDA regulations for product development, clinical trials research, and manufacturing at Duke.
Dr. Parrish is responsible for providing support and guidance to investigators regarding the regulatory and quality requirements relevant to their clinical research activities. She performs a variety of services including regulatory/quality education, regulatory/quality consultation, and support for regulatory submissions. She supports Duke investigators and associated project teams with regulatory needs in a variety of therapeutic areas, including drug, biologic, and device regulatory submissions. She has conducted numerous meetings with the FDA, and her regulatory/GMP experience ranges from early Phase 1 activities through product licensing. She was the primary regulatory project leader for the US approval of the Carolinas Cord Blood Bank BLA and continues to support the regulatory and quality assurance activities associated with the Duke BLA. In addition, Dr. Parrish also oversees and manages implementation of new educational, operational, and collaborative initiatives within ORAQ.
After receiving her undergraduate degree in biology from Emory University, Dr. Parrish worked for two years in a laboratory performing prostate cancer research. She came to Duke University in 2004 to conduct her graduate research studies, where she obtained a PhD in Molecular Cancer Biology with a certificate in Cell and Molecular Biology. Her graduate research focused on regulation of the apoptotic cell death process. Following a short post-doc in her graduate lab and an internship with the Duke Translational Medicine Institute (DTMI) Regulatory Affairs office, in 2010, she moved into a role as a Regulatory Affairs Scientist at Duke University. Dr. Parrish holds the US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
Bruce K. Burnett, PhD, RAC (US & EU)
Director of Regulatory Affairs and Quality
Assistant Professor in Medicine
Phone: (919) 668-7178
Dr. Burnett brings over 25 years of pharmaceutical industry experience involving research and development, scientific affairs, quality control/assurance, and regulatory affairs. He is currently an advisor to the Office of Research Support and Compliance (ORSC) at the National Institutes of Health. Prior to that, he served as the Acting Director of ORSC and helped developed the new office within the Office of the Director. At Duke, he supports clinical research as part of the Regulatory Affairs and Quality group, a group he started in 2007 as part of the Clinical and Translational Science Award grant. Dr. Burnett came to Duke from AlphaVax, a local vaccine biotech company where he last served as Vice President of Quality and Regulatory Affairs. He has also held senior positions in both regulatory and quality at Biogen, Genetics Institute (Wyeth Pharmaceuticals), and Serono (now Merck Serono).
Dr. Burnett received his undergraduate degree in chemistry from the University of California, San Diego and his PhD in chemistry/biochemistry from MIT working in the laboratory of Nobel Laureate Dr. Har Gobind Khorana. He completed an NIH postdoctoral fellowship in genetics at Harvard Medical School.
Dr. Burnett’s regulatory experience includes working on license applications that have resulted in the US approval of Tysabri (natalizumab), Amevive (alefacept), Neumega (oprevelkin, IL-11) and Benefix (coagulation Factor IX). He has also been responsible for preparing and submitting multiple initial INDs to CBER or CDER, preparing for many pre-IND, End of Phase 2 and Pre-Submission device meetings, as well as leading numerous teleconferences with Agency reviewers. The Office of Regulatory Affairs and Quality support over 125 INDs at Duke and oversaw the writing, submission, approval and maintenance of a Biologics License Application for the manufacture of a cord blood product at Duke University (DuCord).
Erika Segear, PhD, RAC
Associate Director of Regulatory Affairs
Phone: (919) 668-4639
Erika Segear, PhD, RAC is the Associate Director of Regulatory Affairs in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Segear works with a team of Regulatory Affairs professionals who serve as a no cost resource to the clinical research community at Duke University.
Dr. Segear is responsible for providing guidance and support to Duke sponsor-investigators in various aspects of regulatory affairs, including regulatory strategy development, preclinical testing, product manufacturing, FDA meetings, regulatory submissions, and regulatory education. She assists project teams with the development, coordination, and implementation of complex regulatory projects in a variety of therapeutic areas, including drugs, biologics, devices, tobacco products and dietary supplements. She has conducted numerous meetings with the FDA and her regulatory experience ranges from early Phase 1 activities through late stage product development. In addition to regulatory work, Dr. Segear also oversees and manages implementation of new educational, operational, and collaborative initiatives within ORAQ.
Dr. Segear received her undergraduate degree in Biology from Penn State Erie, The Behrend College. She conducted her graduate research studies at Duke, where she earned a PhD in Molecular Cancer Biology with a certificate in Cell and Molecular Biology. During her graduate training, Dr. Segear was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. She was also selected to participate in the Duke Scholars in Molecular Medicine Program in Endocrinology and Metabolism. Dr. Segear holds the US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
Dan Ozaki, M.P.H
Manager, Quality Assurance
Phone: (919) 668-6469
Dan Ozaki, MPH, RQAP-GLP, is a Quality Assurance Manager in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In his role, Mr. Ozaki manages the Quality Systems Unit of the Duke Human Vaccine Institute Current Good Manufacturing Practices Program (DGP), a program dedicated to the production of early phase clinical material for first-in-man Human Immunodeficiency Virus (HIV) vaccine trials. The Quality Systems Unit is responsible for the oversight of both quality assurance and quality control activities surrounding vaccine manufacture compliant to Good Manufacturing Practices.
Mr. Ozaki received his undergraduate degree in Psychology from Duke University and his Master’s degree in Public Health from the University of North Carolina at Chapel Hill. Prior to his work at ORAQ, Mr. Ozaki served as the Deputy Director for the Quality Assurance for Duke Vaccine Immunogenicity Program which provided quality assurance oversight to Good Clinical Laboratory Practice (GCLP) compliant labs at Duke. Mr. Ozaki is a Registered Quality Assurance Professional in Good Laboratory Practice with the Society of Quality Assurance.
Patrick Killela, PhD, RAC
Manager, Quality Assurance
Phone: (919) 684-8269
Patrick Killela, PhD, RAC is a Quality Assurance Manager in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Killela is responsible for providing support and guidance to investigators and Molecular Products and Cell Therapy (MPACT) regarding Good Manufacturing Practice (GMP). Dr. Killela assists the MPACT facility in developing and maintaining current Good Manufacturing Practice (cGMP) compliant systems (Standard Operating Procedures; SOPs), training, facilities, equipment, process, and test methods appropriate for the phase of clinical development. This includes review of batch records and approval of Certificates of Analysis for release of any clinical material.
Dr. Killela received his undergraduate degree in biological sciences from North Carolina State University and then worked as a research associate in the Preston Robert Tisch Brain Tumor Center at Duke. Dr. Killela conducted graduate research at Duke University, where he earned his PhD in Pathology. His research resulted in development of a novel classification tool to aid neuropathologist’s in glioma diagnosis worldwide. Prior to his work at ORAQ, Dr. Killela was a Project Leader at the Duke Clinical and Translational Science Institute where he led cross-functional teams to drive project initiatives and quality activities involving both biologics and medical devices. Dr. Killela holds the US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.
Administrative Assistant &
Training Program Coordinator
Phone: (919) 668-0502
Susan Nagorski is the Administrative Assistant and Training Program Coordinator for the Office of Regulatory Affairs and Quality within the Duke University School of Medicine. She supports the entire ORAQ staff by coordinating meetings and maintaining all office operations. Additional duties include website management, expense processing, maintaining two departmental databases, and support with regulatory submissions as needed. Susan also functions as the coordinator of the Regulatory Affairs Training Program. Susan has a BS in Sociology from Western Carolina University and a Technical Excellence Certificate from Duke University Learning and Organization Development.